Our Life Sciences industry expert Tutor, Gerry Burke, makes some suggestions as to how Medical Device, Pharma and Biopharma manufacturers can make the best use the ongoing pause in FDA Inspections. The FDA has stated that it has ‘no plans to resume foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency’ according to RAPS.org*.
Manufactures should use this time wisely, take stock of current compliance level and ensure that their operations are ‘audit ready’ when the FDA resumes it inspections. ‘All aspects of manufacturers’ operations will have come under strain during the COVID-19 pandemic and regulatory compliance is no exceptions’ says Gerry.
Business is beginning to return to normality, and conducting business during a pandemic has almost become a way of life, now is an appropriate time to begin the process of ensuring that levels of compliance also return to the normally high standards that are expected in the Life Sciences industry. Check out the infographic highlighting the key areas to address during the Inspections Pause to be better prepared for the return of Inspections in the near future. (*The full RAPS article can be found here)
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